Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Living Donor Renal Transplantation - A Study to Evaluate the Avoidance of Long-term Nephrotoxic Calcineurin Inhibitor Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor kidneys.
研究概览
简要总结
The purpose of this study is to observe in a randomized prospective study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with the investigators standard treatment protocol of Zenapax® and maintenance immunosuppression.
详细描述
To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with our standard treatment protocol of Zenapax® and maintenance immunosuppression (vide infra).
To determine the effect different antibody induction regimen on the lymphoid cell subsets of the immune system in kidney allograft recipients peripheral blood and bone marrow aspirates will be tested at surgery before transplantation and at intervals post operatively.
To treat renal transplant patients successfully in the absence of long-term calcineurin inhibition to determine if there are beneficial effects on the prevention of chronic allograft nephropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >14 years
- •Weight >40 kg
- •Primary renal allograft:living related (non HLA identical) and unrelated donor
- •Negative standard cross match for T-cells
- •Signed and dated consent form
排除标准
- •Patient has previously received or is receiving an organ transplant other than kidney
- •Patient has received a kidney transplant from a non-heart beating donor
- •Patient has received an ABO incompatible donor kidney
- •Recipient or donor is seropositive for human immunodeficiency virus (HIV)
- •Patient has a current malignancy or a history of malignancy
研究组 & 干预措施
1mg/kg Thymoglobulin
LD kidneys receiving 1mg/kg Thymoglobulin for 7 days starting at the day of surgery.
干预措施: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab (Drug)
Campath-1H at 0.3 mg/kg
Recipients of LD kidneys receiving Campath-1H at 0.3 mg/kg once on the day of surgery and again 3 days post-operatively.
干预措施: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab (Drug)
Zenapax 1 mg/kg
Recipients of LD kidneys receiving Zenapax 1mg/kg on the day of surgery followed by the same dose every 2 weeks for a total of 5 dosages.
干预措施: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab (Drug)
结局指标
主要结局
To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor kidneys.
时间窗: 3 years
Patient/graft survival.
时间窗: 1 and 3 yrs.
次要结局
- Incidence of adverse reactions.(1 & 3 years.)